TERRIBLE DESPAIR OF ANIMALS CUT UP IN NAME OF RESEARCH

Extract from the Daily Express, 21 September 2000, by Lucy Johnston
and Jonathan Calvert

THE SHOCKING TRUTH behind Britain's most high-profile animal experimentation
project is revealed today in confidential documents seen by the
Daily Express.

The secret papers show horrific animal suffering despite claims
to the contrary. They also reveal researchers have exaggerated the
success of work aimed at adapting pig organs for human transplant.

The project, carried out by Cambridge-based Imutran, involves transplanting
genetically modified pigs' hearts and kidneys into monkeys. Thousands
of pigs, monkeys and baboons have been used.

Over the past five years Imutran - the world leader in xenotransplantation
- claims to have been close to solving the crucial issue of organ
rejection which has so far prevented trials on humans.

But the Daily Express found scientific papers declaring new breakthroughs
did not give the full picture. In one published paper it is claimed
no baboons died from "hyperacute" reaction when two excluded
from the published study did.

A second publication describes a baboon which survived for 39 days
with a pig heart - the company's greatest success to date - as healthy
throughout. But records show that it was suffering in the last days
of its life. Its heart had grown in weight by three times, a significant
fact not mentioned in the published article.

Internally, the company admits to being a long way off targets
set by the American Food and Drug Administration for trials on humans.
It wants "substantial" improvements from its scientists
in the next 18 months.

The experiments are being carried out at the Huntingdon Life Science's
animal research laboratories in Cambridgeshire.

Imutran says the animals do not suffer. But the laboratory technicians'
own detailed records of the animals post-transplant lives paint
a different picture. One monkey which had a pig heart attached to
the blood vessels in its neck was seen holding the transplant which
was "swollen red" and "seeping yellow fluid"
for most of the last days of its life.

Animals are described as quiet, huddled, shivering, unsteady and
in spasm. Some had swellings, bruising or were seen with blood or
puss seeping from wounds. Others vomited, or suffered from diarrhoea.

Imutran was given a special dispensation by the Home Office to
carry out this work because of potential benefits to humankind.
It has a duty to ensure the animals suffer as little as possible.

But documents show that over a quarter of the animals died on the
operating table or within a few days because of "technical
failures" in the surgical procedures. In one experiment, this
accounted for 62 per cent of lives. In another, 13 out of 22 monkeys
died within two days of the operation, a fact not mentioned in their
published paper. Imutron maintains all the relevant data was included
in the scientific paper. There have been a number of awful mistakes.
One monkey had to be "sacrificed" when researchers discovered
the pig kidney it was about to be given had been mistakenly frozen.
In the documents, Imutran acknowledges that it has had "severe
problems" with the data. The documents have gone to animal
rights group, Sheffield-based Uncaged Campaigns, which compiled
a report - Diaries of Despair - to present to the Government calling
for a halt to xenotransplantation research and an independent judicial
enquiry. The group's director Dan Lyons said: "The documents
show the true extent of the suffering of these primates. This atrocious
suffering must stop."

An Imutran statement yesterday said: "We should like to emphasise
that animal welfare is very important to Imutran. The conduct of
our animal experimentation is closely monitored by the Home Office."

Last night Dr Gill Langley, a member of the Government's Animal
Procedures Committee, expressed concern. "These documents reveal
the PR image and the reality of xenotransplantation research. It
seems even the scientific community isn't being given the full facts."

---------

THE BABOON BEGAN ITS LIFE in the scrubland and sparse trees of
a Kenyan savannah. Its final days were spent in a cramped, stainless
steel-framed cell, four thousand miles away in Cambridgeshire.

It had become baboon number X201m - one of the thousands of residents
in Europe's biggest animal research laboratory, the Huntingdon Research
Centre, owned by Huntingdon Life Sciences.

The barbed wire exterior of the sprawling complex is patrolled
by security guards who keep a wary eye on groups of activists who
gather outside to protest against vivisection.

None of this could be seen from the baboon's new home - the top
secret Room 099 - where the light is regulated by the flick of a
switch every 12 hours and the air changed every four minutes by
extractor fan.

The monotony was broken on the morning of March 23, 1998, with
a flurry of activity. Baboon X201m was carried to the operating
table, where it took five hours to cut away its healthy heart and
replace it with the heart of a pig.

It is called xenotransplantation - a highly controversial experiment
which some believe will one day be the solution to the shortage
of organs for human transplants.

Baboon X201m clung to life for 39 days after the operation, which
makes him the world's longest survivor with a pig's heart.

His owners, Imutran, the Cambridge company which financed the experiment,
hailed it as a huge success and devoted a scientific paper to him.
But all was not quite as it seemed.

Until now, the full details of Imutran's experiments on live primates
have been a closely guarded secret. The company carefully filters
the little information that has been released.

It claims to be on the verge of a breakthrough which will make
it possible for a human being to live with a pig's heart or kidney.
And it insists that the animals in its experiments do not suffer.

Today the Daily Express can expose the reality. A volume of confidential
documents - the largest set of data on animal experiments ever leaked
- suggests that the company has not been frank with the public and
the scientific community.

It also shows that many animals have endured days or weeks of suffering
in vain.

The documents have shocked a senior government adviser on animal
experiments and led to calls for the work to be stopped. Even baboon
X201m was not the success he was made out to be. His short life
with a pig's heart was announced to the world in a dry academic
paper for the Journal of Heart and Lung Transplantation.

It suggested that the baboon had led a perfectly normal life following
its operation, stating: "Throughout the first 38 post-transplant
days the baboon was active and energetic, moving freely about his
enclosure."

But that is not the picture revealed in detailed scientific records
of the baboon's last days, seen by the Daily Express.

Two weeks after his operation experts noted he was: "Quiet
and huddled, reluctant to move, some abdominal breathing seen, slightly
unsteady."

His condition rallied but in the last 10 days of his life he was
often only "occasionally active". None of this is recorded
in the company's published data. Neither is the fact that his pig
heart had astonishingly grown to three times its weight by the time
he was eventually "sacrificed".

Indeed the five other animals in the experiment lasted, on average,
just 10 days - which again is not mentioned in the paper.

Yesterday, the company defended its description of the monkey in
the paper. "We have video recordings made late in the animal's
post-operative course at 25 days and 35. This footage shows an active
and energetic animal, climbing in its enclosure."

Over the past five years Imutran has used the services of Hunting-don
Life Sciences to perform more than 400 transplants on primates.

The experiments are aimed at overcoming the problems of rejection
caused by the body's natural immune reaction to foreign organs such
as hearts and kidneys.

Imutran became world leaders in the research when they developed
"transgenic" organs which have been genetically altered
to reduce the chances of rejection.

They have been testing ways of keeping the transplanted animals
alive using a variety of drugs to suppress the immune system.

The rewards for success could be huge. Optimistic City forecasts
are that the industry could be worth £6billion by the year
2010. In particular, it will open a huge market for the immuno-suppressant
drugs produced by Imutran's parent company, the Swiss drug giant,
Novartis.

Ever since the mid-nineties the company has been declaring boldly
that it is within a year of extending the tests to humans. Yet documents
seen by the Daily Express suggest that it has given a highly selective
account of its achievements.

A paper published in the journal of Transplant Proceedings last
year claimed the company had made a key breakthrough in eradicating
the problem of "hyperacute" rejection - in which the monkey's
immune system reacts instantly against the donated pig heart.

It said that a study of nine baboons who had a pig heart sewn onto
their arteries showed that no "transgenic heart underwent hyperacute
rejection". But secret data shows the experiment was actually
carried out on 22 baboons. The company picked nine out of the ten
baboons who had lived longest, probably because they were on different
drug regimes. Two of those excluded from the published paper died
after suffering a "hyperacute" rejection to the organ.

The reality that emerges is that the company is still a long way
off making xenotransplantation work in humans.

The company's raw data from the two major experiments carried out
at Huntingdon shows that, on average, a baboon survives only seven
days after having its heart replaced by that of a pig.

And it is clear the longest survivors were kept alive with massive
doses of drugs. They have had more success transplanting kidneys
into monkeys, but new problems have been discovered, such as cancer
and internal bleeding, possibly caused by the drugs.

The crisis came to a head at a recent meeting between Imutran and
senior managers in Novartis. An 18-month deadline was set for the
research to show "substantial" increases in survival rates.

The lack of progress will increase pressure on the company to justify
its experiments. By law, vivisection is only licenced if the benefit
to mankind outweighs the harm to animals.

Until now, little has been known about the treatment of the monkeys
inside Huntingdon LIfe Sciences. Publicly, Imutran insists they
"don't suffer". But its own documents show for the first
time the true horrifying extent of the ordeal endured by the monkeys.

They are transported halfway across the globe in tiny cages. In
one shipment three animals died - probably from suffocation - in
a 35-hour trip from the Philippines. All the animals used for xenotransplantation
experiments at HLS die or are killed. It can be a long exit - a
research goal is to keep the animals alive as long as possible after
transplant.

Clinical conditions are recorded by scientists. Animals are described
as quiet, huddled, shivering, unsteady, in spasm, vomiting and suffering
from diarrhoea. Some have blood or puss seeping from wounds.

A baboon with a pig's heart transplanted onto its neck had swelling
around the transplant and "yellow fluid around wound".

Some animals are found dead in their cages and others are "sacrificed"
when their condition goes past the point of no return. Many deaths
are wasteful. In one experiment, 33 out of 61 monkeys died within
24 hours of a transplant due to "technical failures".
The company's correspondence shows an average of one in five animals
lost this way.

Imutran says its work is monitored by the Home Office and regards
animal welfare as "very important". There is much evidence
of shoddy work inside the centre. The documents show animals have
been wrongly re-used in experiments, medicines have been left unlabelled
and uncapped, and on hundreds of occasions scientists have failed
to take readings and measurements from animals following operations.

Worse still, there are mistakes which lead to painful deaths. A
monkey perished because a swab had been left inside his wound during
the operation, causing his spleen to go septic. Another had to be
"sacrificed" when researchers discovered the pig kidney
it was to be given had been frozen by mistake.

A female monkey had to be euthanased the day after she was given
a dose of a drug four times higher than recommended.

The records note that she was shaking and grinding her teeth. Imutran
later wrote to the laboratory, saying the mistake was "unacceptable".

"Imutran says the animals do not
suffer. But the laboratory technicians' own detailed records of
the animals post-transplant lives paint a different picture."